Back to resultsCompensatory Cognitive Training For Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Compensatory Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, compensatory cognitive training, generalized estimating equation, psychosocial correlates, self-stigma
Eligibility Criteria
Inclusion Criteria:
- diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
- age from 20 to 65
- attending day care center regularly for at least 3 months
- taking stable dose of medication for at least 3 months
Exclusion Criteria:
- comorbid autism spectrum disorder
- comorbid mental retardation
- lacking the reading and writing skills
Sites / Locations
- Taoyuan Psychiatric Center Ministry of Health and Welfare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CCT+TAU group
TAU group
Arm Description
The participants in CCT+TAU group received compensatory cognitive training plus treatment as usual. The CCT intervention consisted of two 50-minute sessions each week for 10 weeks
The participants in TAU group received usual treatment at the same time as CCT+TAU group.
Outcomes
Primary Outcome Measures
Change scores of Rosenberg Self-Esteem Scale (RSES)
The Chinese version of Rosenberg Self-Esteem Scale (RSES) was implemented as self-esteem measures. The total score ranged from 10 to 40, with higher scores reflecting higher levels of self-esteem.
Change scores of General Self-Efficacy Scale (GSES)
The Chinese version of General Self-Efficacy Scale (GSES) consisted of 10 items, assessing optimistic self-beliefs to cope with a variety of difficult demands in life. The total score ranged from 10 to 40, with higher scores indicating more self-efficacy.
Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.
Change scores of Internalized Stigma of Mental Illness (ISMIS)
The Chinese version of Internalized Stigma of Mental Illness (ISMIS) consists of 29 items incorporated in five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance. The total scores range from 29-116. The higher scores on the ISMIS indicates more severe internalized stigmatization.
Secondary Outcome Measures
Full Information
NCT ID
NCT04040998
First Posted
July 26, 2019
Last Updated
July 30, 2019
Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04040998
Brief Title
Compensatory Cognitive Training For Schizophrenia
Official Title
Compensatory Cognitive Training for Psychosocial Correlates and Self-stigma in Persons With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, compensatory cognitive training, generalized estimating equation, psychosocial correlates, self-stigma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCT+TAU group
Arm Type
Experimental
Arm Description
The participants in CCT+TAU group received compensatory cognitive training plus treatment as usual. The CCT intervention consisted of two 50-minute sessions each week for 10 weeks
Arm Title
TAU group
Arm Type
No Intervention
Arm Description
The participants in TAU group received usual treatment at the same time as CCT+TAU group.
Intervention Type
Behavioral
Intervention Name(s)
Compensatory Cognitive Training
Intervention Description
Teach the participants compensatory cognitive skills and strategies
Primary Outcome Measure Information:
Title
Change scores of Rosenberg Self-Esteem Scale (RSES)
Description
The Chinese version of Rosenberg Self-Esteem Scale (RSES) was implemented as self-esteem measures. The total score ranged from 10 to 40, with higher scores reflecting higher levels of self-esteem.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
Title
Change scores of General Self-Efficacy Scale (GSES)
Description
The Chinese version of General Self-Efficacy Scale (GSES) consisted of 10 items, assessing optimistic self-beliefs to cope with a variety of difficult demands in life. The total score ranged from 10 to 40, with higher scores indicating more self-efficacy.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
Title
Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Description
The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
Title
Change scores of Internalized Stigma of Mental Illness (ISMIS)
Description
The Chinese version of Internalized Stigma of Mental Illness (ISMIS) consists of 29 items incorporated in five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance. The total scores range from 29-116. The higher scores on the ISMIS indicates more severe internalized stigmatization.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
age from 20 to 65
attending day care center regularly for at least 3 months
taking stable dose of medication for at least 3 months
Exclusion Criteria:
comorbid autism spectrum disorder
comorbid mental retardation
lacking the reading and writing skills
Facility Information:
Facility Name
Taoyuan Psychiatric Center Ministry of Health and Welfare
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
12. IPD Sharing Statement
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Compensatory Cognitive Training For Schizophrenia
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